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EndoSerter

by CorneaGen

Ref ES-1

EndoSerter (ES-1) is a device classified as Class IIa in the EU and Class I in the US made by CorneaGen, registered in EUDAMED on 22 Aug 2023 (Basic UDI-DI B-00855934007003) and listed in FDA GUDID since 3 Nov 2020 (UDI-DI 00855934007003), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00855934007003 Basic UDI-DI 00855934007003UDI-DIDate22 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00855934007003 UDI-DI Date3 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00855934007003 registered 22 Aug 2023 Active
  • FDA GUDID UDI-DI 00855934007003 listed 3 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00855934007003
  2. Registered EUDAMED B-00855934007003

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Donor cornea delivery set
Model / Ref / Catalog
ES-1
Primary DI / UDI-DI
00855934007003
Basic UDI-DI
B-00855934007003
FDA product code
OTZ
EMDN code
Q020299 Cornea explantation and transplantation devices - other
GMDN term
Donor cornea delivery set
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4300
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000028846
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under CORNEA EXPLANTATION AND TRANSPLANTATION DEVICES - OTHER.

Other devices from CorneaGen

See all devices from CorneaGen →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)